Quality Management Systems

Our Quality Management System serves as the foundation for Banner Medical. We are FDA 820 compliant and have received ISO 13485 certification for the manufacture of implantable and instrument products for the medical device industry. All of our processing equipment has gone through the IQ, OQ, and PQ validation process, and we can confirm that our machining processes maintain the material’s original properties and characteristics.

Another key element in our Quality Management System is the ability to maintain all pertinent documentation regarding material traceability. Per FDA 820.60, FDA 820.65, ISO 13485, and ISO 14971, all manufacturers must maintain raw material traceability throughout the supply chain and production process. We have built-in protocol to assure traceability to melt source as part of the incoming inspection process for all materials received. We can also supply and maintain traceability information in standardized or custom form as part of the Device History Record for any OEM or Contract Manufacturer we serve.

All value-added services (internal or external to Banner Medical) must comply with our quality systems and validation processes. Each of our value-added services is fully validated in accordance with FDA, ISO, ASTM, and OEM specifications that are pertinent to the service required. Maintaining this structure assures quality in every aspect of our product and service portfolio.